Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2026-01-24 @ 7:52 PM
Study NCT ID:
NCT02385604
Status:
COMPLETED
Last Update Posted:
2016-03-10
First Post:
2015-03-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Predictive Value of CT-PET in Esophageal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-09', 'studyFirstSubmitDate': '2015-03-02', 'studyFirstSubmitQcDate': '2015-03-05', 'lastUpdatePostDateStruct': {'date': '2016-03-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'Undetermined'}, {'measure': 'Disease-free survival', 'timeFrame': 'Undetermined'}], 'secondaryOutcomes': [{'measure': 'Histopathologic response', 'timeFrame': 'Undetermined', 'description': 'Mandard tumor regression grade, ypT, ypN stage'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Positron-Emission Tomography', 'Neoadjuvant Therapy', 'Chemoradiotherapy', 'Esophagectomy', 'Response Evaluation Criteria in Solid Tumors', 'Treatment Outcome', 'Survival', 'Recurrence', 'Disease-Free Survival', 'Progression-Free Survival', 'Prognosis', 'Neoplasm Grading', 'Adenocarcinoma', 'Squamous Cell Carcinoma', 'Neoplasm Metastasis'], 'conditions': ['Esophageal Neoplasms']}, 'referencesModule': {'references': [{'pmid': '24045450', 'type': 'BACKGROUND', 'citation': "Donohoe CL, O'Farrell NJ, Grant T, King S, Clarke L, Muldoon C, Reynolds JV. Classification of pathologic response to neoadjuvant therapy in esophageal and junctional cancer: assessment of existing measures and proposal of a novel 3-point standard. Ann Surg. 2013 Nov;258(5):784-92; discussion 792. doi: 10.1097/SLA.0b013e3182a66588."}, {'pmid': '23470576', 'type': 'BACKGROUND', 'citation': 'Piessen G, Petyt G, Duhamel A, Mirabel X, Huglo D, Mariette C. Ineffectiveness of (1)(8)F-fluorodeoxyglucose positron emission tomography in the evaluation of tumor response after completion of neoadjuvant chemoradiation in esophageal cancer. Ann Surg. 2013 Jul;258(1):66-76. doi: 10.1097/SLA.0b013e31828676c4.'}, {'pmid': '25351460', 'type': 'RESULT', 'citation': "Elliott JA, O'Farrell NJ, King S, Halpenny D, Malik V, Muldoon C, Johnston C, Reynolds JV. Value of CT-PET after neoadjuvant chemoradiation in the prediction of histological tumour regression, nodal status and survival in oesophageal adenocarcinoma. Br J Surg. 2014 Dec;101(13):1702-11. doi: 10.1002/bjs.9670. Epub 2014 Oct 28."}]}, 'descriptionModule': {'briefSummary': 'A major focus of research in oncology is to identify patients who, following induction therapy, have a complete pathologic response, presenting opportunities for novel trials, including extended therapy or non-operative approaches, in addition to identifying cohorts who are resistant to the neoadjuvant therapy. The current gold standard for determining response to CRT is pathological evaluation following surgical resection, in particular the Mandard Tumour Regression Grade (TRG) or some modification thereof. At this time, however, there is no preclinical early response or post-treatment biomarker, nor endoscopic or radiologic assessment that predicts pathologic response prior to surgical resection.The aim of this study is to determine the accuracy of CT-PET for prediction of histopathologic response and/or oncologic outcome for patients with esophageal cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Records for all patients with locally advanced esophageal and junctional tumors undergoing potentially curative multimodal therapy between November 2008 and November 2014 will be assessed.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Locally advanced esophageal or junctional neoplasm\n* Histologically confirmed adenocarcinoma or squamous cell carcinoma\n* Scheduled to undergo nCRT followed by surgery as per multidisciplinary Tumor Board\n* CT-PET at diagnosis of malignancy (within 2 weeks from diagnosis), performed at study Center\n* CT-PET 4-6 weeks after completion of nCRT, prior to surgical resection\n\nExclusion Criteria:\n\n* Incomplete data, patient lost to follow-up\n* Scans performed at alternate Center'}, 'identificationModule': {'nctId': 'NCT02385604', 'briefTitle': 'The Predictive Value of CT-PET in Esophageal Cancer', 'organization': {'class': 'OTHER', 'fullName': "St. James's Hospital, Ireland"}, 'officialTitle': 'CT-PET for Prediction of Histopathologic Response, Nodal Status and Oncologic Outcome Following Neoadjuvant Chemoradiation for Esophageal Cancer', 'orgStudyIdInfo': {'id': '12/009/2011'}}, 'contactsLocationsModule': {'locations': [{'zip': 'D4', 'city': 'Dublin', 'country': 'Ireland', 'facility': "Department of Surgery, St. James's Hospital", 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}], 'overallOfficials': [{'name': 'John V Reynolds, MCh FRCS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Department of Surgery, St. James's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. James's Hospital, Ireland", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Surgical Research Fellow', 'investigatorFullName': 'Dr Jessie A Elliott', 'investigatorAffiliation': "St. James's Hospital, Ireland"}}}}